Change-sensitive Measurement of Emotion Dysregulation in ASD

描述(由申请人提供)：自闭症谱系障碍(ASD)患者通常由于情绪调节不良和情绪困扰而需要精神护理。只有两种精神药物被批准用于自闭症，这两种药物都是用来治疗表现为脾气暴躁、情绪爆发和攻击性的易怒情绪。然而，导致这些问题行为的情绪调节的潜在缺陷却鲜为人知，也很少在治疗中进行测量或针对性的研究。全面情绪失调(如抑郁、情绪爆发、情绪崩溃等)的循证治疗方法在ASD中并不存在。在这一领域取得进展的一个主要障碍是缺乏针对自闭症患者的有效的、治疗敏感的情绪困扰措施。本项目建议完善和验证一种新的自闭症情绪困扰和情绪调节测量方法，称为情绪调节障碍量表(EDI)。将利用患者报告的结果测量信息系统(PROIS)项目的指导方针和黄金标准统计方法来完成EDI的校准和心理测量分析。主要样本将包括来自社区、门诊和精神科住院机构的1000名患有自闭症的儿童和年轻人的照顾者。数据收集将通过在线系统进行。分析将集中于建立EDI的因素结构/维度，开发不到10个条目的简表，建立收敛和发散的效度，比较预期得分不同的群体(例如，住院患者和社区样本；自闭症和健康对照)之间的EDI得分，并将EDI得分与两个专科精神科住院儿童表现出的情绪失调发作的观察计数进行比较。样本的一个子集将完成两次EDI，以建立重测可靠性。EDI检测治疗变化的能力将通过比较两个专门治疗自闭症的精神科住院病房入院和出院时照顾者和提供者评级的EDI分数和稳定社区样本中的4周变化分数来确定。这项研究的主要结果将是一个用户友好的(例如，在线提供的，简短的)，验证的，治疗敏感的ASD临床试验的结果衡量标准，独立于言语能力。此外，这项研究将产生现有关于ASD情绪失调的最大数据集，这些数据集将用于确定这一人群的情绪特征和治疗需求。EDI中额外的时间进程问题，利用个人的情绪失调历史，将有助于临床概念化，并有助于理解自闭症固有的情绪失调与共病精神障碍之间的界限。最后，对自闭症患者的情绪失调进行敏感的测量将有助于理解遗传和神经成像研究中的异质性，并将使跨人群研究成为可能。

DESCRIPTION (provided by applicant): Individuals with autism spectrum disorder (ASD) are often in need of psychiatric care due to poor emotion regulation and emotional distress. Only two psychotropic medications have been approved for use in ASD, both to treat irritability expressed as tantrums, outbursts, and aggression. However, the underlying deficits in emotion regulation that lead to these problem behaviors are poorly understood and rarely measured or targeted in treatment. Evidence-based treatment approaches for the full range of emotion dysregulation (e.g. depression, outbursts, meltdowns, etc.) present in ASD do not exist. A major barrier to progress in this area is a lack of validated, treatment sensitive measures of emotional distress for individuals with ASD. This project proposes to refine and validate a new measure of emotional distress and emotion regulation for ASD, called the Emotion Dysregulation Inventory (EDI). Guidelines from the Patient-Reported Outcome Measurement Information System (PROMIS) Project and gold-standard statistical approaches will be utilized to complete calibration and psychometric analysis of the EDI. The primary sample will include caregivers of 1000 children and young adults with ASD from community, outpatient, and psychiatric inpatient settings. Data collection will occur through an online system. Analyses will focus on establishing the EDI's factor structure/dimensionality, developing a less than 10-item short form, establishing convergent and divergent validity, comparing EDI scores among groups whose scores would be expected to differ (e.g. inpatients versus community sample; ASD versus healthy controls), and comparing EDI scores to observational counts of emotion dysregulation episodes displayed by children who are inpatients on two specialized psychiatric units. A subset of the sample will complete the EDI twice to establish test-retest reliability. The EDI's ability to detect treatment change will be determined by comparing both caregiver- and provider-rated EDI scores at admission and discharge across two psychiatric inpatient units that specialize in ASD and 4-week change scores in a stable community sample. The primary outcome of this study will be a user-friendly (e.g. available online, brief), validated, treatment sensitive outcome measure for clinical trials in ASD that is independent of verbal ability. In addition, this study will produce he largest existing dataset on emotion dysregulation in ASD, which will be used to identify emotional profiles and treatment needs in this population. Additional time-course questions in the EDI that tap the individual's history of emotion dysregulation will be useful for clinical conceptualization and helping to understand the boundaries between emotion dysregulation that is inherent in ASD and comorbid psychiatric disorders. Finally, having a sensitive measure of emotion dysregulation in ASD will aid in understanding heterogeneity in genetic and neuroimaging research and will enable cross-population studies